AzTrials
AzTrials

Peripheral T-cell LymphomaPhase 1/2TOUCHNCT04425070

A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma

A Phase 1/2 study testing ICE [ifosfamide+carboplatin+etoposide], GEMOX [gemcitabine+oxaliplatin] and Tislelizumab in people with Peripheral T-cell Lymphoma and NK/T-cell Lymphoma, run by Antengene Corporation at 13 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE [ifosfamide+carboplatin+etoposide] or GEMOX [gemcitabine+oxaliplatin] or Tislelizumab), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ICE [ifosfamide+carboplatin+etoposide], GEMOX [gemcitabine+oxaliplatin] and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
13 sitesChina
Study dates
18 Aug 2020to 30 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is willing to provide written ICF.
  • Age≥ 18 years.
  • R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016.
  • Previously received at least one or more standard regimens including anthracycline.
  • Recurrence or the recurrence disease after the last treatment completed.
  • At least one measurable disease per modified efficacy assessment criteria (Cheson 2014).
Show all 9Show fewer
  • ECOG PS 0 or 1.
  • Any toxicity caused by previously anti-tumor therapy must recovered to ≤ Grade 1 (NCI-CTCAE v5.0) with exception of hearing loss, alopecia, and pigmentation.
  • Expected life time longer than 3 months.

Who cannot join

  • Current have disease or history of central nervous system lymphoma.
  • HBV-DNA positive, or HCV-RNA positive.
  • Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
  • Received major surgery within 4 weeks of first dose of study drug
  • Known received SINE, including ATG-010.
  • Unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption.
Show all 9Show fewer
  • Known allergy to ATG-010, or ICE, or GEMOX.
  • A woman who is pregnant or nursing.
  • The investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Beijing Tongren Hospital.CMU

    Beijing, Beijing Municipality, 100005

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210000

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Tianjin Medical Universisity Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Phase 1/2, Open-label, Multi-center Study to Evaluate theSafety and Efficacy of Selinexor Combined With Chemotherapy orTislelizumab in Relapsed or Refractory Mature T and NK Cell Lymphoma

This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE [ifosfamide+carboplatin+etoposide] or GEMOX [gemcitabine+oxaliplatin] or Tislelizumab), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.

Read the detailed description

This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients. 97 patients are planned to be enrolled.

Being tested
ICE [ifosfamide+carboplatin+etoposide], GEMOX [gemcitabine+oxaliplatin], Tislelizumab
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, Extranodal NK-T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICE [ifosfamide+carboplatin+etoposide]Combination product

    • Combined with ICE chemotherapy regimen:
    • Ifosfamide: 5 g/m2, continuous intravenous (iv) infusion (mesna 5 g/m2 synchronously iv infusion for rescue), on Day 2;
    • Carboplatin: with concentration-area under time curve (AUC)=5 (highest concentration to 800 mg), iv infusion, on Day 2;
    • Etoposide l00 mg/m2, iv infusion, on Days 1-3;
    • ATG-010 60 mg/once, oral, on Days 4 and 11. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).

  • GEMOX [gemcitabine+oxaliplatin]Combination product

    • Combined with GEMOX chemotherapy regimen:
    • Gemcitabine 1000 mg/m2, iv infusion, on Days 1 and 8;
    • Oxaliplatin 130 mg/m2, iv infusion, on Day 1;
    • ATG-010 60 mg/once, oral, on Days 2 and 9. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).

  • TislelizumabCombination product

    Tislelizumab will be administered intravenously at a fixed dose of 2 0 0 mg every 3 weeks on Day 1 of each cycle

Study groups in NCT04425070
Study groupRoleWhat they receive
ATG-010 + ICEExperimentalATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11
Receives: Combination Product: ICE [ifosfamide+carboplatin+etoposide]
ATG-010 + GEMOXExperimentalATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9
Receives: Combination Product: GEMOX [gemcitabine+oxaliplatin]
ATG-010 + TislelizumabExperimentalATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle
Receives: Combination Product: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs/SAEs

    Toxicity will be graded according to the NCI CTCAE, Version 5.0.

    Measured: 18 months

  2. Overall Response Rate (ORR)

    To determine the overall response rate according to Chenson 2014.

    Measured: 18 months

Secondary outcomes (4)

  1. Duration of response (DOR)

    Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.

    Measured: 18 months

  2. Disease control rate (DCR)

    Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD)

    Measured: 4 weeks to 18 months

  3. Progression-free survival (PFS)

    Duration of time from the first dose of study drug until progression or death due to any cause

    Measured: 18 months

  4. Overall Survival (OS)

    Duration of time from the first dose of study drug until death due to any cause

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start18 Aug 2020
  3. Primary completion30 Dec 2025
  4. Study completion30 Dec 2025

Why it stopped: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
ATG-010 + ICE ATG-010 + GEMOX ATG-010 + Tislelizumab
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04425070
Sponsor's protocol ID
ATG-010-T/NK-001
Acronym
TOUCH
Status last verified
Dec 2025
First submitted
25 May 2020
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu C, Li D, Gao Y, Zhang W, Guo Z, Zhao J, Huang H, Tao R. Selinexor plus tislelizumab in patients with relapsed/refractory natural killer/T-cell lymphoma after failure of PD-1 blockade: the phase 1b TOUCH trial. Oncologist. 2026 Aug 6;31(9):oyag266. doi: 10.1093/oncolo/oyag266.

    PubMed 42438166

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICE [ifosfamide+carboplatin+etoposide], GEMOX [gemcitabine+oxaliplatin] and Tislelizumab in people with Peripheral T-cell Lymphoma and NK/T-cell Lymphoma, run by Antengene Corporation at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs/SAEs (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04425070, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in